A Randomized Multi-Centre Controlled Trial of Large Diameter (36/40 mm) Versus Conventional Diameter (32 mm) Femoral Heads for the Prevention of Post Revision Arthroplasty Dislocation
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- To compare the difference in dislocation rate between those receiving a large ball (36/40 mm femoral head) versus those receiving a 32 mm femoral head in patients who undergo revision hip arthroplasty
研究概览
简要总结
About ten percent of revision hip replacements will dislocate. Although dislocation is not a life-threatening problem, it is stressful and costly and requires hospitalization to treat. Subjects who have repeated dislocations live with the constant fear of another dislocation. The purpose of this study is to test the effectiveness of a large ball prosthesis in preventing post-surgical dislocation. A large diameter ball has greater freedom of movement before it impinges; therefore, theoretically, it should not dislocate as easily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients will be those undergoing revision hip arthroplasty, either first revision or subsequent re-revision.
- •Revision must require replacement of both the acetabular component and femoral component, except when revising femur only with well-fixed Trilogy socket.
- •The acetabular component must have a minimum outer diameter of 50 mm.
- •The femoral component inserted should be a Zimmer Versys™ beaded full-coated stem or Zimmer ZMR™ stem or collarless polished taper (CPT™)
- •Patients must be able to reply to questionnaires in either French or English.
排除标准
- •Patients who are undergoing revision for recurrent dislocation.
- •Revision of the acetabulum requiring structural allograft or reconstruction ring.
- •Revision of the acetabulum requiring the use of cemented all-polyethylene cups.
- •Revision of the acetabulum using a liner cemented into an existing metal shell.
- •Intra-operative decision to use a constrained liner.
结局指标
主要结局
To compare the difference in dislocation rate between those receiving a large ball (36/40 mm femoral head) versus those receiving a 32 mm femoral head in patients who undergo revision hip arthroplasty
时间窗: at two years
次要结局
- To compare the difference in functional and quality of life measures in the two groups(at 3, 12 and 24 months post surgery)
- To compare radiographic findings in the two groups
- To estimate the rate of re-revision in the two groups
- To compare polyethylene wear in the two groups